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Romosozumab - Amgen/UCB

Drug Profile

Romosozumab - Amgen/UCB

Alternative Names: AMG-785; Anti-sclerostin; Anti-sclerostin monoclonal antibody; CDP-7851; EVENITY; Sclerostin Ab

Latest Information Update: 18 Jan 2019

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At a glance

  • Originator ChiroscienceGroup plc
  • Developer Amgen; UCB
  • Class Monoclonal antibodies; Osteoporosis therapies
  • Mechanism of Action SOST protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Male osteoporosis; Postmenopausal osteoporosis
  • Discontinued Fracture

Most Recent Events

  • 16 Jan 2019 The US FDA's Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) recommends approval of romosozumab for Postmenopausal osteoporosis
  • 08 Jan 2019 Amgen Astellas and Astellas will co-promote Romosozumab for Postmenopausal osteoporosis and Male osteoporosis in Japan
  • 08 Jan 2019 Registered for Male osteoporosis in Japan (SC) - First global approval
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